Liposomal Bupivacaine With Dexamethasone for Foot Surgery

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Rothman Institute Orthopaedics
Study ID
NCT06465992
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Ankle Surgery
  • Foot Surgery
  • Popliteal Nerve Block
  • Post Operative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Exparel 266 MG Per 20 ML Injection — DRUG
    20 mL Liposomal bupivacaine (Exparel, 266 mg) will be administered in the popliteal and saphenous block
  • Bupivacaine Hcl 0.75% Inj — DRUG
    10 mL of 0.75% bupivacaine will be administered in popliteal and saphenous block
  • Dexamethasone — DRUG
    1 mL of 10 mg Dexamethasone will be administered in the popliteal and saphenous block

Study Details

This study aims to understand the ideal formulation to utilize in saphenous nerve and popliteal nerve blocks for foot and ankle procedures. It will examine the use of liposomal bupivacaine alone or liposomal bupivacaine with dexamethasone prior to foot and ankle procedures in peripheral nerve blocks. We will compare liposomal bupivacaine (Exparel) and liposomal bupivacaine (Exparel) combined with dexamethasone to determine if the addition of dexamethasone significantly decreases postoperative narcotic use and prolongs analgesic effects when administered in a popliteal and saphenous block prior to foot and ankle orthopedic procedures.

Key Dates

Start date
Jun 17, 2024
Status verified
Jun 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Study Group 1: Foot/Ankle Surgery with Exparel Nerve Block
    Prior to participants surgical procedure, the anesthesiologist will administer a popliteal and saphenous nerve block consisting of 20 mL Liposomal bupivacaine (Exparel) + 10 mL of 0.75% bupivacaine
  • Active Comparator: Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block
    Prior to participants surgical procedure, the anesthesiologist will administer a popliteal and saphenous nerve block consisting of 20 mL Liposomal bupivacaine (Exparel) + 1 mL of 10 mg preservative free Dexamethasone + 10 cc's of 0.75% bupivacaine

Primary Outcome Measure

Amount of pain medication used after surgery [ Time Frame: 14 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rothman Orthopaedic InstitutePhiladelphiaPennsylvania19107-

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Rothman Orthopaedic Institute· Philadelphia, PA

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